NCT06719687

Sd-RAB for the Diagnosis of PPLs

Self-driving Robotic-assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Lesions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, prospective, and single-arm study. The purpose of this study is to evaluate the feasibility and safety of a new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary lesions.

Detailed description

Self-driving robotic-assisted bronchoscope (Shanghai MicroPort MedBot (Group) Corporation Limited, China) is a new robotic-assisted bronchoscopic system that can automatically advance through airway according to the preoperative planning path under the guidance of electromagnetic navigation. It can also be controlled manually by the operator. In this study, 30 patients will be prospectively enrolled to evaluate the feasibility and safety of this new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary lesions. The primary endpoint of this study is the complication rate. The secondary endpoints include navigation success rate, diagnostic yield, rate of rEBUS confirmation, total examination time, navigation time, and duration of finding lesions.

Conditions

• Peripheral Pulmonary Lesions

Interventions

Type	Name	Description
DEVICE	Self-driving robotic-assisted bronchoscope	All procedures will be performed under general anesthesia with endotracheal intubation and mechanical ventilation. The self-driving robotic-assisted bronchoscope will automatically advance through airway to the target lesion according to the preoperative planning path under the guidance of electromagnetic navigation. After that, the bronchoscopist will use radial endobronchial ultrasound (rEBUS) to confirm the lesion localization. The choice of biopsy tools (eg. forceps, needles, brush, etc.) will be left to the discretion of the bronchoscopist.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2024-12-06
• Last updated: 2024-12-06

Locations

1 site across 1 country: China